The medicine was sold by a variety of retailers, including CVS, Family Dollar and Walmart.

"There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury," Tris Pharma said in a news release. "Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects."

So far, the company says it has received no reports of infants injured as a result of taking the recalled ibuprofen.